URONORM 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Uronorm, 5 mg, coated tablets
3. Uronorm, 10 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet
4. What is Uronorm and what is it used for
5. Important information before taking Uronorm
   1. When not to take Uronorm:
   2. Warnings and precautions
   3. Children and adolescents
   4. Uronorm and other medicines
   5. Uronorm with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Uronorm contains lactose
6. How to take Uronorm
   1. Use in children and adolescents
   2. If you take more Uronorm than you should
   3. If you forget to take Uronorm
   4. If you stop taking Uronorm
7. Possible side effects
   1. If you experience any of the following side effects, stop taking Uronorm and seek medical help immediately:
   2. Other side effects:
   3. Very common (may affect more than 1 in 10 people):
   4. Common (may affect up to 1 in 10 people):
   5. Uncommon (may affect up to 1 in 100 people):
   6. Rare (may affect up to 1 in 1,000 people):
   7. Very rare (may affect up to 1 in 10,000 people):
   8. Frequency not known (cannot be estimated from the available data):
   9. Reporting of side effects
8. How to store Uronorm
9. Contents of the pack and other information
   1. What Uronorm contains
   2. What Uronorm looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Uronorm, 5 mg, coated tablets

Uronorm, 10 mg, coated tablets

Solifenacin succinate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet

• 1. What is Uronorm and what is it used for
• 2. Important information before taking Uronorm
• 3. How to take Uronorm
• 4. Possible side effects
• 5. How to store Uronorm
• 6. Contents of the pack and other information

1. What is Uronorm and what is it used for

The active substance of Uronorm belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This allows for longer intervals between visits to the toilet and increases the amount of urine held in the bladder. Uronorm is used to treat symptoms of an overactive bladder. These include: sudden, urgent need to urinate, frequent urination, and involuntary loss of urine, because the patient cannot get to the toilet in time.

2. Important information before taking Uronorm

When not to take Uronorm:

• if you are allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6)
• if you have difficulty emptying your bladder or cannot empty your bladder (urinary retention)
• if you have severe gastrointestinal disorders (including toxic megacolon, a complication of ulcerative colitis)
• if you have a muscle disorder called myasthenia gravis, which can cause significant weakness of certain muscles
• if you have increased pressure in the eye, which can lead to a gradual loss of vision (narrow-angle glaucoma)
• if you are undergoing hemodialysis
• if you have severe liver impairment
• if you have severe kidney disease or moderate liver disease and are taking medicines that may delay the elimination of Uronorm from the body (e.g., ketoconazole). Your doctor will provide information on this.

Before starting treatment with Uronorm, tell your doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

Before taking Uronorm, discuss with your doctor or pharmacist:

• if you have difficulty emptying your bladder or urinating (narrowing of the urethra). In this case, the risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have gastrointestinal disorders (constipation)
• if there is a risk of slowed movement of food through the digestive system (gastrointestinal motility). Your doctor will provide information on this.
• if you have severe kidney impairment
• if you have moderate liver impairment
• if you have a burning sensation in the stomach (hiatus hernia) or heartburn
• if you have autonomic nervous system disorders (autonomic neuropathy).

Before starting treatment with Uronorm, tell your doctor if any of the above situations apply or have applied in the past. Before starting treatment with Uronorm, your doctor will assess whether there are other causes of frequent urination, such as heart failure (insufficient strength of the heart muscle to pump blood) or kidney disease. If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial medicine).

Children and adolescents

Uronorm should not be used in children or adolescents under 18 years of age.

Uronorm and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those you have bought without a prescription. It is especially important to tell your doctor if you are taking:

• other anticholinergic medicines, as taking such a medicine with Uronorm may increase the intensity of both the therapeutic effect and the side effects of both medicines
• cholinergic receptor agonists, as they may weaken the effect of Uronorm
• gastrointestinal motility enhancers, such as metoclopramide and cisapride, as Uronorm may weaken their effect
• medicines such as ketoconazole, itraconazole (used to treat fungal infections), ritonavir, nelfinavir (used to treat HIV infections), verapamil, diltiazem (used to treat high blood pressure and heart disease), as they slow down the metabolism of Uronorm
• medicines such as rifampicin (used to treat tuberculosis and other bacterial infections), phenytoin, carbamazepine (used to treat epilepsy), as they may accelerate the metabolism of Uronorm
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Uronorm with food and drink

Uronorm can be taken with or without food, depending on the patient's preference.

Pregnancy and breastfeeding

Uronorm should not be used during pregnancy, unless it is absolutely necessary. Uronorm should not be used during breastfeeding, as solifenacin passes into breast milk. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Uronorm may cause blurred vision, dizziness, drowsiness, and fatigue. If you experience these side effects, do not drive or operate any machinery.

Uronorm contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Uronorm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is 5 mg once a day, unless your doctor advises you to take a dose of 10 mg once a day. Swallow the tablet whole with a drink of water, e.g., a glass of water. Uronorm can be taken with or without food, depending on the patient's preference. Do not crush the tablets.

Use in children and adolescents

Uronorm should not be used in children or adolescents under 18 years of age.

If you take more Uronorm than you should

If you have taken too many Uronorm tablets or if a child has taken some, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention), and dilated pupils.

If you forget to take Uronorm

If you miss a dose, take the next dose as soon as possible, unless it is almost time for the next dose. Do not take Uronorm more than once a day. If you are not sure, ask your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose.

If you stop taking Uronorm

If you stop taking Uronorm, the symptoms of an overactive bladder may return or worsen. Stopping Uronorm should always be discussed with your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Uronorm can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Uronorm and seek medical help immediately:

• allergic reaction or hypersensitivity reaction, with severe anaphylactic reactions and severe skin reactions (e.g., blistering and peeling of the skin), which have been reported.
• angioedema (a type of allergic skin reaction that causes swelling of the skin and mucous membranes), with swelling of the airways (difficulty breathing), which has been reported in some patients taking solifenacin succinate.

Other side effects:

Very common (may affect more than 1 in 10 people):

• dry mouth.

Common (may affect up to 1 in 10 people):

• blurred vision,
• constipation, nausea, dyspepsia with symptoms such as: feeling of fullness, abdominal pain, belching, nausea, heartburn, discomfort in the stomach.

Uncommon (may affect up to 1 in 100 people):

• urinary tract infection, cystitis
• drowsiness, taste disturbances,
• dry eye syndrome,
• dry nose,
• gastroesophageal reflux disease (heartburn), dry throat,
• dry skin,
• difficulty urinating,
• fatigue, fluid accumulation in the legs (edema).

Rare (may affect up to 1 in 1,000 people):

• dizziness, headache,
• accumulation of hard stool in the colon; obstruction (blockage) of the colon, vomiting,
• itching, rash,
• difficulty urinating despite a full bladder (urinary retention).

Very rare (may affect up to 1 in 10,000 people):

• hallucinations, confusion,
• hives.

Frequency not known (cannot be estimated from the available data):

• decreased appetite, increased potassium levels in the blood, which can cause heart rhythm disturbances,
• sudden confusion (delirium),
• increased pressure in the eye,
• irregular heartbeat (Torsade de Pointes), changes in the electrical activity of the heart (ECG), palpitations, rapid heartbeat,
• voice disorders,
• intestinal obstruction, discomfort in the abdomen,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Uronorm

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton, blister, and label after EXP. The expiry date refers to the last day of that month. There are no special storage precautions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Uronorm contains

• The active substance of Uronorm is solifenacin succinate. Each coated tablet contains 5 mg or 10 mg of solifenacin succinate, which corresponds to 3.8 mg or 7.5 mg of solifenacin.
• The other ingredients are:
• tablet core: lactose monohydrate, maize starch, hypromellose 2910 (5 cP), colloidal anhydrous silica, magnesium stearate
• coating: hypromellose 2910 (6 cP), macrogol 4000, titanium dioxide (E 171), talc, and: 5 mg: iron oxide yellow (E 172), 10 mg: iron oxide red (E 172).

What Uronorm looks like and contents of the pack

Coated tablet (tablet)
5 mg: light yellow, round, biconvex coated tablets with the marking "CC" on one side and "31" on the other side. The diameter of the tablet is 7.6 mm.
10 mg: light pink, round, biconvex coated tablets with the marking "CC" on one side and "32" on the other side. The diameter of the tablet is 7.6 mm.
Pack sizes:
3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets in blisters.
100 tablets in a plastic container.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer/Importer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the package leaflet: